Agent Staves Off Complications of Abortion

Action Points

This study found that for women having a first-trimester abortion by vacuum evacuation, cervical preparation with misoprostol (Cytotec) resulted in fewer complications than not using anything at all.

There were, however, more side effects -- most commonly abdominal pain and vaginal bleeding -- in the misoprostol group in the hours before the abortion.

For women having a first-trimester abortion by vacuum evacuation, cervical preparation with misoprostol (Cytotec) resulted in fewer complications than not using anything at all, a randomized trial showed.

The rate of complications within the first two weeks after the abortion was 2% for women who received vaginal administration of misoprostol and 3% in the placebo group (RR 0.68, 95% CI 0.47 to 0.96), according to Eduardo Bergel, PhD, of the World Health Organization (WHO) Department of Reproductive Health and Research in Geneva, and colleagues.

The difference was driven by a reduction in incomplete abortions (RR 0.35, 95% CI 0.21 to 0.58), most of which required re-evacuation, the researchers reported online in The Lancet.

There were, however, more side effects -- most commonly abdominal pain and vaginal bleeding -- in the misoprostol group in the hours before the abortion.

"If cervical preparation with misoprostol is done before vacuum aspiration abortion, providers should be aware of the side effects of the drug and inform women about these effects," the authors wrote.

An important step in abortion by vacuum aspiration is dilation of the cervical canal, and that has been achieved using osmotic dilators, mifepristone (Mifeprex), and prostaglandin analogs -- including misoprostol.

Although misoprostol's effects on cervical dilation are well known, no studies have been large enough to assess complications from using it before a first-trimester abortion by vacuum aspiration.

So Bergel and colleagues recruited 4,972 healthy women seeking an abortion at 12 weeks of gestation or less at 14 centers in nine countries (Armenia, Slovenia, Hungary, Vietnam, Mongolia, India, China, Cuba, and Romania). The mean age of the participants was 27.

Half were randomized to vaginal administration of two 200-µg tablets of misoprostol three hours before the abortion or two placebo tablets. The researchers followed the women for two weeks.

As seen in previous studies, misoprostol resulted in a larger cervical diameter -- allowing for a larger suction tube -- and less need for additional mechanical dilation.

The primary outcome of the trial was the rate of immediate or delayed complications, including cervical tear, uterine perforation, incomplete abortion, uterine re-evacuation, pelvic inflammatory disease, or any other serious adverse event.

In terms of the immediate complications, there were no cervical tears and three uterine perforations in the misoprostol group, and two cervical tears and one uterine perforation in the placebo group. The between-group differences were not significant.

Incomplete abortions occurred in less than 1% of the misoprostol group and 2% of the placebo group. Most of those patients required uterine re-evacuation. To avoid one re-evacuation, the authors noted, 72 women would need to be treated with misoprostol.

There were no between-group differences in the rate of pelvic inflammatory disease (1% in each group) or other serious adverse events (less than 1% in each group).

The primary side effects that occurred in the three-hour treatment period before the abortion -- and were more common with misoprostol -- were abdominal pain (55% versus 22%) and vaginal bleeding (37% versus 7%). None of the women required medical intervention.

In an accompanying editorial, Allan Templeton, MBChB, of the University of Aberdeen in Scotland, pointed out that the "WHO's guideline on safe abortion recommends routine cervical preparation only for pregnancies of more than 12 weeks and, although not against general use, remains concerned with the time and side effects between misoprostol and surgery, despite the evidence presented in [the current] trial."

"Surely," he said, "routine pharmaceutical dilation of the cervix should be recommended as an integral part of surgical abortion in all women."

Bergel and colleagues acknowledged that the study was limited in that the staff administering the treatments were not blinded to group assignment, few women with gestations longer than 11 completed weeks were included because of a misunderstanding, and there was a lack of statistical power for the analysis of specific complications and subgroups.

The study was supported by the UNDP/UNFPA/WHO/World Bank Special Program of Research, Development, and Research Training in Human Reproduction at the Department of Reproductive Health and Research of the World Health Organization, and the Packard Foundation.

POPULAR IN YOUR SPECIALTY

MedPageToday is a trusted and reliable source for clinical and policy coverage that directly affects the lives and practices of health care professionals.

Physicians and other healthcare professionals may also receive Continuing Medical Education (CME) and Continuing Education (CE) credits at no cost for participating in MedPage Today-hosted educational activities.